Medical device CE marking

Revision 1 issued of MDCG 2019-13 on sampling MDR and IVDR for the assessment of the technical documentation

2024-12

The MDCG issued revision 1 of the Guidance on sampling of MDR Class IIa /Class IIb and IVDR Class B / Class C devices for the assessment of the technical
documentation.

The document can be downloaded in our library.

Source: European Commission